An Update Regarding The FDA’s Letter to 23andMe

23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives.23andMe_Logo_blog

It is absolutely critical that our consumers get high quality genetic data that they can trust.   We have worked extensively with our lab partner to make sure that the results we return are accurate.  We stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well.

In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.

In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.

This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.

I am committed to making sure that 23andMe is a trusted consumer product. I believe that genetic information can lead to healthier lives — a goal that all of us share.

We will provide updates as they become available.


  • rkamai

    It is easy to imagine strong arguments on both sides of the 23andme v. the CDC issue. The big question here is why 23andme isn’t more transparent with its users and the general public about what they are doing and intending to do. The rampant speculation fostered by blogs and the media would be best dampered by real and candid information from 23andme. This company is ostensibly about allowing us all to be better informed… why not expand that to include this issue?

  • David W Edsall

    as a physician who has been recommending 23&me to my patients,I am very concerned about this issue. 23&me had better be careful to have no hint of scamming or hyping like the food supplement industry.
    At the same time I think the FDA is corrupt political and subject to bribes. Look at the droperidol and Sugamadex events. looks like bribes to me No sense to ban drugs that safe 1000′s of lives or complications because of an issue that might harm an infinitesimal few.

  • Dilanka Wettewa

    Personally, I think it’s a FANTASTIC idea to have some 3rd party entity have oversight into the accuracy of 23andme’s testing process. How many of you KNOW for sure that the $99 test results you received is in fact ACCURATE? What if it’s not? Are you seriously going to base life altering decisions based on those results?

    I believe 23andme has the best intentions — but, I am not smart enough to know if their testing process (and results) are in fact accurate.

    Having a 3rd party to monitor/audit 23andme’s testing/lab protocol is GREAT….But, the FDA (..or anything else starting with the word “Federal”..) might not be the best entity to carry out the task.

  • Donna Pryor

    I wisht the email 23andme had sent out had been more informative. This update didn’t tell me anything and now I am wondering if I will ever get my test results. I think the FDA is wrong for holding this company back from testing our samples and giving us complete reports. However, 23andme needs to be specific about what is the actual complaint(s), what they are SPECIFICALLY doing to resolve them, give their customers an estimated time line or the opportunity to request a refund. I am very disappointed in how they are handling this issue with their customers and I am angry that the are not telling us anything that is helpful.

  • Brian Hickory

    Why not just move off shore? The Feds want to block progress, let them leave US behind. I also suggest everyone start learning Chinese.

  • Beavis71cox

    @AnneW……it seems to me, that the FDA is concerned with how your website s worded, such as “your risk” and others……it would be possible to change the wording of your website and still provide the same information without being diagnostic…….for example, I can download my raw data at FTDNA, go to GedCom, and run it through their SNP analysis program. I can then take the results and reference to free public SNP databases and find the same studies and results you give. So maybe if you sell your genealogy part for $99 to everyone, then offer the health part as a free upgrade…..you are no longer selling a medical device, but providing free info…….as far as wordings go, instead of listing “risks”, you could just list the diseases. Instead of increased risk, list them as “studies more important to you” and “studies east important to you”. And then on each disease page, instead of listing “you risk”, say something like “your SNP was found in such and such study, and it was found that the people in the group had an (increased or decreased) percentage for risk of the disease.

    In this way, you would no longer be offering diagnostic information, but instead referencing all results to known public studies, and you would be doing it as part of the free health upgrade……..just a thought, but I think it could work

  • Carl

    You couldn’t be more wrong. There is no possible way of meeting the FDA’s insane requirements. It would cost billions of dollars and take 20 years. Not just once but for every update.
    The only thing 23andme can do is keep explaining to the FDA why what they are demanding is insane, and why the FDA is acting outside it’s authority. And keep stalling until they have enough public support and it is a fait accompli.
    Or they can relocate to a free democratic country outside the reach of FDA tyrants.

  • Rick

    I personally, have found the results to be valuable and so far, accurate. I have supplied my results to my doctor also.

    I am concerned about this report and hope to find 23andMe vindicated. I have two people that wanted to do this and I was going to gift but now am waiting to find the true underlying story.

  • Scott23H

    Paul, We do not mail people results. We do let you know when your results are ready. You log in to your account to see your results. You can also download your raw data from your account.

  • Scott23H

    Maggie,
    We actually have a research portal that allows outside researchers to access our data. We’ve also entered into several cooperative research projects with other researchers. (https://www.23andme.com/researchportal/)

  • Kathryn Wolf

    Let’s just expedite the results, people.

  • Larry Popelka

    Check out my Bloomberg Businessweek article on why government regulators are shutting down start-ups like 23andme – its all about protectionism for old-school companies, and it’s hurting us all.
    http://www.businessweek.com/articles/2013-12-02/what-do-government-agencies-have-against-23andme-uber-and-airbnb?

  • jimkress

    You already have the right to know. The government has no Constitutional authority to keep you from knowing. If Congress is going to do anything, it should restrain the FDA from these types of Unconstitutional power grabs.

  • AnonymousArizonan

    It isn’t socialized medicine, it’s an insurance scheme lyingly made out to be socialist medicine so Communists/socialists/corporatists will back it.

    • eric braun

      so, with “capitalized medicine” if you don’t have money you can just go die, right? how is survival of the fittest supposed to work if the poor can’t get fit?

      and, as if ayn rand didn’t take SS after she got cancer (which, as a right-wing lunatic she blamed on liberals rather than her smoking)…PFFT!!

  • AnonymousArizonan

    Wrong. Those patents are bye-bye. It was ruled they can’t own other people’s genes to prevent them from seeking second opinions, other test sources, or other doctors.

  • Jiri Dluhos

    Please keep fighting, don’t allow bureaucrats to stop you! I mostly consider FDA pretty sane, but this case seems to be an exception. :-) Your work is extremely useful, not only for the data it provides, but also that it shows that crowd knowledge can advance our knowledge! This is, I believe, crucially important. Good luck 23andme, we are with you! (Or at least I am.)

  • AnonymousArizonan

    DNA testing/genome mapping is not medical, and is not comparable to medical things.
    Laws on food, drugs, and cosmetics can’t touch 23andMe, and would have no business discussing such businesses at all.
    Such businesses need their own laws, designed to protect people from their DNA being used without their consent, let alone patented, or profited off.
    I think the FDA is trying to get the DNA from 23andMe for it’s true owners to do exactly those unethical actions with it.
    There is a dire need for a law to be written, passed, and put into affect stating that only those carrying a gene legally own it, and that they must all give consent for it to be used for profit, cloning, or insertion into GMOs (that must be specified to include “designer babies”). And, this law must be not only nationally enforced, without exception, and with the highest possible punishments for breaking this law (execution would be best – scientific rape, and kidnapping deserve to be considered among the most horrific things a scientist could ever do), but arrangements must be made with other countries to make their scientists also adhere to this law concerning citizens of countries with such laws.

  • WotAWarld

    I don’t know about US English, but in Canadian English and English English reporting on a risk of something happening is not saying that it has actually happened, does not prevent it happening and does not fixing up the results of it happening.

    So that stating there is an increased risk of something does not cure, mitigate, treat, prevent or diagnose anything.

    Next thing the FDA will outlaw people telling each other, “You’re fair skinned, you should use a strong sunscreen.”

    “And any kit intended to cure, mitigate, treat, prevent, or diagnose a disease is, according to federal law, a “medical device” that needs to be deemed safe and effective by the FDA.”

  • WotAWarld

    Kernos, there is nothing stopping you from doing charity yourself and donating testing kits to poor people.

    Charity is primarily something we should do ourselves, not something we should tell other people to do (unless they are enormously wealthy, Steve Jobs was).

    But if you mean scientifically, I think more human data is left out by which geographic regions of the world it is marketed in, but that is relieved by various governments, drug companies and universities doing studies around the world.

  • WotAWarld

    The thing is that those are narrow tests looking for just a few things related to cystic fibrosis.

    A test that looks for a few things is comparatively trivial to validate.

    If Illumina wants to market another test, say for MS, the FDA will make them get another round of FDA approvals.

    This would be fine if each FDA approval was relatively streamlined, but it apparently is not.

    Say $300,000 (and it is probably much much more) multiplied by the thousands of disease risks computes out to something even big pharma could not afford, over $300 billion.

  • WotAWarld

    I view 23andMe test results as (a) suggesting questions to ask my doctor about and (b) suggestions of topics to read up on on my own.

    I have never viewed 23andMe test results as being diagnostic. It says right there in the text on the results pages that results are not to be used for diagnosis.

    Certainly the fonts used to make assertions and cautions about the tests not being definitive for diagnosis are big and clear enough on the 23andMe website. IF the FDA wants them in more places or in plainer language, then fine that is reasonable.

    “And any kit intended to cure, mitigate, treat, prevent, or diagnose a disease is, according to federal law, a “medical device” that needs to be deemed safe and effective by the FDA.”

    And on its own, no diagnostic test of any kind marketed by anyone anywhere at any time is ever curative or preventative. So what in the world if the FDA on about?

    If they are not merely want changes to the placement of existing cautions, and maybe simplified language, then I could only guess bureaucratic empire building or maybe protecting big pharma.

  • Alexa

    As a long-time scientist in the pharmaceutical industry, 23andMe’s battle with the FDA frustrates me. The knee-jerk reactions to the FDA’s legitimate concerns in this blog sadden me. True, the FDA’s published comments about possible needless mastectomies were unduly alarming, but I believe they reflect the agency’s frustration with Anne Wojcicki’s “damn the torpedoes, full speed ahead” attitude, which endangers the entire field of easily available genetic testing. It shows a reckless disregard of her obligations to her employees and investors. The FDA-drug industry conspiracy folks fail to realize that 23andMe is a FOR-PROFIT company. They pushed out and widely marketed a test that was not fully validated (fully tested for accuracy, etc.) BECAUSE THEY NEEDED TO MAKE SOME MONEY. You can’t run a company with high research costs without some cash flow (money coming in). They antagonized the FDA with their blatant disregard for generally accepted scientific standards, which makes the folks at the FDA dig in their heels. The FDA has made some huge mistakes in its history, but in general, it is made up of good people trying to do a very difficult job. Anne, genetic testing can’t be done in an HP garage. Grow up.

    • ChristyPeck

      As a long-time pharmaceutical industry scientist you are no doubt aware that pharmaceutical companies are also FOR-PROFIT. The difference being that 23andMe is smaller, newer, and less politically established than most pharmaceuticals who have been working with the FDA over the years. With healthcare costs what they are in these times there is an urgent need for preventive approaches to health care. The availability of genetic tests are simply one means to that end. Please don’t underestimate the public’s intelligence and ability to understand the limitations of usefulness of the results of 23andMe’s tests.

      • Alexa

        ChristyPeck, All of my pharmaceutical industry experience has been with “smaller, newer, and less politically established” startup companies. I completely agree with the need for preventative approaches to health care. The biggest roadblock to affordable preventative care has not been the FDA, but the fact that Medicare and private insurance companies have resisted paying for such care and testing. The problem I have with 23andMe is that much of information (linkage of the presence of certain genes or SNPs to the propensity for various diseases) has not been fully vetted by the general scientific community outside the FDA. The general public unfortunately may not be able to understand this limitation on the results, a fact I blame partly on the shameful deterioration of scientific education in our secondary schools. That being said, I stand by my point that 23andMe’s recklessness may put up unnecessary walls for the rest of the more responsible genetic testing industry. Being new on the scene is no excuse for being politically stupid.

  • Ramin

    It would be good if you give an update on the FDA situation, especially regarding the samples which you received and were already paid for. I haven’t seen anything since the 26/11!!

    Thank you.

  • Brill Pappin

    Does the FDA claptrap effect customers from other countries (like Canada) on only US sales?

  • Corey Chambers

    23andme simply needs to adhere its marketing verbiage to comply with the FDA requirements. I see no words in 23andme’s marketing that specify or imply that the tests “diagnose”, “treat” or “prevent” disease. 23andme is therefore currently in compliance.

    Alberto Gutierrez is in charge of the FDA’s complaint against 23andme:Office of In Vitro Diagnostics and Radiological HealthDirector: Alberto Gutierrez, Ph.D.301-796-5453

    While the FDA often seems to error in saying that everything is a medical device, the FDA will likely come to agreement regarding the personal, non-medical nature of 23andme’s personal genome service.

    Corey Chambers, PrivateGene.org

  • Valerie Olague

    Unfortunately we don’t get to decide what is and is not a medical device. Although I’m astounded that the FDA would consider this service a device, when you read the regulation and it’s description it is clear that they have defined a device to be much broader than a physical thing that can be inserted into a body. Insulin pumps are medical devices and there a lots of things like MRI systems that are not inserted but are clearly medical devices. They have also left it open for non-hardware kinds of things.
    Someone else has mentioned that the issue here is 23andMe marketing, not the service. And the FDA letter does specific that it is how 23andMe is marketing the rest results that makes it a medical device.
    Have the marketing leads for the company considered changing the marketing statements to include wording such as another replier recommended is being used to market dietary supplements?
    I will of course petition, but we need to be real that the FDA is out for power and money. Ignoring them is not an option, nor is telling them that as defined today 23andMe is not a medical device.

  • kelly

    stop hiding under your desk and communicate with your customers!

  • Rodney Wilder

    I sent in my kit a month or so back and received first results late last week, and my family information today. All is fine, I just don’t think they are currently allowed to sell the kit in the USA for now until the fda issue is cleared up

  • Chi

    Howt does the FDA involvement, impact Privacy? Will my data be kept private, or does the FDA believe it has a right to access my data?

  • Chi

    I was told the Government refuses to allow any but Registered Native Americans to access definitive DNA tests that can identify tribe and %. Isn’t that discriminatory?
    HOW can we access having THOSE DNA tests done?

  • Chi

    Exactly! What people choose to do, with their Doc’s advice into the equation, is THEIR business, NOT the FDA’s!
    If someone wants to have prophylactic surgery to preempt breast cancer, fine.
    If someone wants to ignore strong evidence, and wait it out, fine.
    It’s between the person and their Doctor[s], based on science, data, & personal circumstances.
    I am REALLY TIRED of Government [Read: Industries] Micro-managing our lives. Industries are terrified people will stop allowing them to run our lives.
    Follow the money. Monsanto runs the FDA, et al.

  • Chi

    Yep–I knew it! Follow the money. Every time.
    It’s Industries, buying legislator’s votes, micromanaging our lives to pieces.

  • BlahBlahBlah

    This comes from the same FDA that says Walnuts when eaten are a drug.
    http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm

  • amy

    I received my kit just after the FDA announcement. I wanted to make sure I would either 1) get a full refund or 2) get my results if I sent it in. Your customer service is nonexistent. You replied to my inquiry with an email saying the CEO sent an email to all existing customers. False. You will not reply to my questions. If you can’t handle obvious customer services in the face of this type of “crisis” why should we trust you with our DNA?

  • IrateCustomer

    Minutes ago they changed the home page to include the following:

    “Welcome to 23andMe.

    At this time, we have suspended our health-related genetic tests to comply
    immediately with the U.S. Food and Drug Administration’s directive to
    discontinue new consumer access during our regulatory review process.

    We are continuing to provide you with both ancestry-related genetic tests
    and raw genetic data, without 23andMe’s interpretation.

    If you are an existing customer please click the link below and then go to
    the health page for additional information. If you are a customer that
    purchased before 11/22/13, you will still have access to your health-related
    results.

    We remain firmly committed to fulfilling our long-term mission to help
    people everywhere have access to their own genetic data and have the ability to
    use that information to improve their lives.

    Upon entering the site, please confirm you understand the new changes in our
    services.

    I understand that 23andMe only sells ancestry reports and raw
    genetic data at this time. I understand 23andMe will not provide health-related
    reports. However, 23andMe may provide health-related results in the future,
    dependent upon FDA marketing authorization.”

    When I signed up on November 28, 2013, I was led to believe that the service would include medical information. Cancellation will cost me $25 per kit plus shipping costs (the rest will be refunded). Who do I need to contact for a full refund? I am not getting the service I was promised, and may have to do a credit card chargeback. Alternately, give me the information I was promised.

  • Scott23H

    Please see the post from our CEO that went up today. We were unable to answer the questions regarding refunds and access to health results until our conversation with the FDA.

  • Scott23H

    Ofelia,
    You can check the status of your sample by logging on to your account. You can also contact the customer care team directly if there is a problem accessing your data. Got to our help page enter your questions. If there isn’t an answer for your question we have a link to email the customer care team directly.

    • Ofelia

      I received my results the next morning after my comment. I was very excited to get them. Thanks!

  • Scott23H

    Gogo, Please take a look at the latest update regarding the FDA and our customers. We are also emailing customers directly with details about how this will impact our service. We were unable to answer those questions until today’s meeting with the FDA.

  • Scott23H

    We are complying with the FDA order. Please see our update regarding the FDA that was put up today. Thanks.

  • Scott23H

    Gaby, If you purchased your kit before November 22nd you will still have access to health and ancestry reports. Please take a look at our updated response to the FDA.

  • Scott23H

    Kathy, Please take a look at the updated statement regarding the FDA order that was posted today.

  • Scott23H

    Yes your sample will still be processed.

  • Scott23H

    Lucy, Please take a look at the update posted today. We were unable to answer many of these questions until we received clarification from the FDA which didn’t occur until today.

  • Scott23H

    Michael, I’ve been told that the email to customers will be sent shortly.

  • Scott23H

    We don’t offer sequencing at this time. We are a genotyping service (although we have done some limited sequencing for research). You can download your raw data and use it however you wish.

  • eric braun

    Have
    you all considered a “we the people” petition to the whitehouse? how
    many customers do you have who you could email? i am sure most of your
    customers are as happy with your service as i have been and are ready to
    get fighting mad!

    this is supposed to be a free country! it’s my dollar and my DNA!!!

  • Dana

    I don’t know if Brin’s right about the FDA getting money from Big Pharma–I don’t see how that would work, precisely, since FDA officials are not elected and hence do not have to run campaigns. However, there *is* a revolving door between Monsanto and the FDA. Someone who cared enough to do the research might Google around and see if there are similar revolving doors involving the pharmaceutical companies as well. It’s not like the federal government polices any of this very closely.

    And if you’re about to say “this is outrageous”, you’re absolutely right. So why is it legal?

  • Laura Henze Russell

    I’ve just launched a Tweet Race: @POTUS @FLOTUS @VP @DrBiden @23andMe: #Free23andMe! #FDAisClass3! Health=Truth #23andMe #FDAhttp://www.facebook.com/hiddenriver pic.twitter.com/H7zPLvdlVp Pick up your whistle & spread the song!

Return to top